GET TESTED INTERNATIONAL AB distributed 1 unit nationwide in the United States. The device lacked premarket approval or clearance. Stop using the product immediately and contact GET TESTED INTERNATIONAL AB for instructions.
Distribution without premarket approval/clearance.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GET TESTED INTERNATIONAL AB or your healthcare provider for instructions. Notification method: Letter
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Drug test kit designed to screen for four substances. It is sold as a medical device under Health & Personal Care products.
Distribution without premarket approval or clearance means the product lacks regulatory authorization to be marketed in the United States. This can affect test validity and safety.
This recall is not part of a broader industry pattern.
Consumers may be exposed to unapproved testing devices. The recall requires immediate stop-use to reduce potential regulatory and safety risks.
Recall notice and FDA enforcement page for identifiers and instructions.
Not specified in the recall notice.
Retain recall notice, photos of packaging, receipts, and correspondence with the manufacturer.
Model numbers: EAN 7340221701045; SKU A-DR4; UDI-DI: None; Lot/Serial Number: All Lots. Sold nationwide in the US. Price: Unknown.
No injuries or incidents have been reported.
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